Honey based wound dressing

ABSTRACT

The present invention is directed to the use of honey in medical dressings. Preferred embodiments modify honey with a viscosity increasing agent, resulting in a range of possible compositions including ointments and salves, self-adhesive gels such as for use on mouth ulcers and pustules, and pliable or flexible sheets which can be used as a wound covering. Preferred viscosity increasing agents include both particulate and continuous gels, respective examples of each including agars and alginates. Selected honeys preferably, but not necessarily, exhibit antibacterial properties other than what is merely conferred by osmolarity and sugar concentration effects.

TECHNICAL FIELD

[0001] The present invention is directed to the use of honey in medicaldressings Preferred embodiments modify honey with a viscosity increasingagent resulting in a range of possible compositions including ointmentsand salves, self-adhesive gels such as for use on mouth ulcers andpustules, and pliable or flexible sheets which can be used as a woundcovering.

[0002] Alternatively the invention may be viewed as an improvement onprior art “moist wound dressings” by incorporating honey in the gel topotentially confer to such dressings antibacterial properties,anti-inflammatory properties, debriding qualities, and promotion ofgrowth of wound tissue

BACKGROUND ART

[0003] The use of honey in treating wounds have been long known, withsuch use being recorded in 4,000 year old Sumerian clay tablets. Thereare continuing records of its use throughout history, with an increasingnumber of medical reports near the beginning of this century. Recentlythe antibacterial properties of honey and its potential use as a wounddressing has attracted greater attention.

[0004] Recent international medical literature record honey as beingeffective as a dressing for wounds, burns and skin ulcers. Recordedobservations include that inflammation, swelling and pain are quicklyreduced, that sloughing of necrotic tissue occurs without the need fordebridement, and that growth of tissues to repair the wound isstimulated. As a consequence, healing occurs rapidly with minimalscarring, and often without any necessity for skin rafting.

[0005] Work by the inventor and others has helped to establish that theeffectiveness has been due primarily to anti-microbial properties ofhoney. Healing processes will not usually occur unless infection iscleared from a lesion, and investigations involving swabbing woundsdressed with honey has shown that infecting bacteria are rapidlycleared.

[0006] In this respect honey appears superior to the expensive modernhydrocolloid wound dressings which are favoured in the art as a moistdressing. Although tissue re-growth in the healing process is enhancedby a moist environment, and deformity is reduced if the re-growth is notforced down by a dry scab forming on the surface, moist conditions alsofavour the growth of infecting bacteria. The difficulty facing the priorart is that antibiotics are ineffective in this situation whileantiseptics cause tissue damage and thus slow the healing process. Incontrast, honey causes no tissue damage and appears to actually promotethe healing process.

[0007] While there is a need for moist dressings within the art,investigations involving honey as wound dressings have focussedprimarily on unmodified honeys. As mentioned above, dressing wounds withhoney has been the most prevalent form of investigation, essentiallyattempting to maintain raw honey in contact with a wound as part of amoist dressing. However, while such methods may be useful forinvestigative trials, the techniques can be relatively time consuming toapply and maintain, and may be impractical in a number of situations.

[0008] A primary cause of this is the relatively fluid nature of mosthoneys—i.e. honey is runny at body temperature. Due to this fluidity,especially at body temperature, localising honey to the desired area maybe difficult. Difficulties may be less for an incapacitated person in ahospital bed, though these difficulties generally preclude its use as asimple wound dressing on an active person.

[0009] Containment of unmodified honey is thus a problem, and no simplepractical solution has been proposed. The soaking of absorbentmaterials, such as gauzes, in a dressing to be applied over a wound andthen held in place by a further covering is a possibility though tendsto be messy and would be difficult to apply except in a clinicalsituation. Even then applying such a dressing can be relatively timeconsuming and require the use of an excessive number of relativelyexpensive sterilised coverings.

[0010] Another problem is that many wounds exude moisture and thiscauses the problem of further dilution of the honey exacerbatingcontainment problems, especially where there is pressure on the dressingcausing the diluted honey to be squeezed out. This dilution of the honeymay also introduce other considerations such as a potential reduction inantibacterial activity due to dilution.

[0011] Accordingly, while the anti-bacterial properties of honey havebeen acknowledged, there are a number of practical problems to beovercome before honey can find widespread use as a practical dressingfor wounds and other medical uses.

[0012] Similarly there are a number of problems associated with priorart ‘moist’ wound dressings, such as of the alginate type. The moistenvironment provided by these types of dressings favours the growth ofmicroorganisms and accordingly they cannot be used on infected wounds,even though this may otherwise be the preferred choice of dressing. Theuse of many antibiotics have also failed to keep unwanted microbialgrowth in check when ‘moist-type’ dressings are used in certainsituations of this type. Accordingly, medicine cannot always make use ofthe full potential of moist prior-art dressing types.

[0013] Reference will be made throughout the specification to theanti-microbial properties of honey. It is acknowledged that this isknown in the art and a number of publications survey these properties.It is anticipated that a skilled addressee of the art would be familiarwith the teachings of these publications insofar that many honeyspossess antimicrobial properties, with some exhibiting more activitythan others. Consequently, this document shall not seek to establishthat certain honeys do possess anti-microbial properties, nor shall itseek to set out a specific list comparing the properties of all honeyswhich may or may not have been publicly documented. Again it will berelied upon that anti-microbial properties associated with honey havebeen established in the prior art By way of reference, some relevantdocuments which address this are given:

[0014] Molan, P. C. (1992) The antibacterial activity of honey. 1. Thenature of the antibacterial activity. Bee World 73 (1): 5-28.

[0015] Molan, P. C. (1992) The antibacterial activity of honey. 2.Variation in the potency of the antibacterial activity. Bee World 73(2): 59-76.

[0016] Willix, D. J.; Molan, P. C.; Harfoot, C. J. (1992) A comparisonof the sensitivity of wound-infecting species of bacteria to theantibacterial activity of manuka honey and other honey. Journal ofApplied Bacteriology 73: 388-394.

[0017] Cooper, R. A.; Molan, P. C. (1999) The use of honey as anantiseptic in managing Pseudomonas infection. Journal of Wound Care 8(4): 161-164.

[0018] Cooper, R. A.; Molan, P. C.; Harding, K. G. (1999) Antibacterialactivity of honey against strains of Staphylococcus aureus from infectedwounds. Journal of the Royal Society of Medicine 92: 283-285.

[0019] A number of publications describe the large amount of variationin potency of antibacterial activity between different honeys. Thevariation can be as much as one-hundred-fold, and is due to varyinglevels of antibacterial factors in honey additional to the sugar contentand acidity in which there is little variation.

[0020] A patent document of some interest is U.S. Pat. No. 5,177,065 bySilvetti. This document references the manufacture of wound dressingsincorporating high levels of monosaccharides. In this document, it isthe osmotic properties of concentrated sugar solution which are ascribedas providing any bactecriostatic effect. Consequently the describedinvention of Silvetti, and claims, concentrate on film-like compositionsbased on individual mono-saccharides or mono-saccharide blends

[0021] A very brief reference to honey is made in the prior artdiscussion of Silvetti, though only in terms of dismissing honey as afolk medicine which would appear to have no useful anti-bacterial effectin a wound healing preparation, such as the subject of thatspecification. Accordingly, while this document is of some interest, itteaches away from the use of honey in a wound covering form orcomposition, and instead teaches towards the use of predominantlymonosaccharide solutions.

[0022] Accordingly, it is an object of the present invention to addressthe problems associated with the prior art, or at least to provide thepublic with a useful choice. It also appears from the prior art that theuse of honey in a medicinal sense is useful though difficultiesassociated with its use prevent its full potential from being realised,and hence the present invention also seeks to address this.

[0023] Further aspects and advantages of the present invention willbecome apparent from the ensuing description which is given by way ofexample only.

DISCLOSURE OF INVENTION

[0024] According to one aspect of the present invention there isprovided a medical composition comprising the combination of one or morehoneys with a viscosity increasing agent.

[0025] According to another aspect of the present invention there isprovided a medical composition, substantially as described above, inwhich at least 50% of the composition is honey.

[0026] According to another aspect of the present invention there isprovided a medical composition, substantially as described above, inwhich the viscosity increasing agent is an alginate based material.

[0027] According to another aspect of the present invention there isprovided a medical composition, substantially as described above, inwhich the viscosity increasing agent is a natural product based gellingagent.

[0028] According to another aspect of the present invention there isprovided a medical composition, substantially as described above, inwhich the combination is such that the resulting composition is in theform of a firm, non-running gel.

[0029] According to another aspect of the present invention there isprovided a medical composition, substantially as described above, inwhich the viscosity of the gel composition is such that it is suitablefor application as an ointment or salve.

[0030] According to another aspect of the present invention there isprovided a medical composition, substantially as described above, inwhich the viscosity of the gel composition is such that it is suitablefor extrusion to fill wound cavities

[0031] According to another aspect of the present invention there isprovided a medical composition, substantially as described above, inwhich the gel-formed composition is substantially non-running at bodyheat.

[0032] According to another aspect of the present invention there isprovided a medical composition, substantially as described above, inwhich the gel-formed composition is substantially non-running at 45° C.

[0033] According to another aspect of the present invention there isprovided a medical composition, substantially as described above, inwhich the gel-formed composition includes moisture absorbing, trapping,or removing agents suitable for removing exudate from a wound such thatthe gel-formed composition remains substantially non-running for anextended period of time after application to a wound when compared to asimilar composition in which the said water trapping, removing orabsorbing agents are absent.

[0034] According to another aspect of the present invention there isprovided a medical composition, substantially as described above, inwhich the combination of honey(s) and viscosity increasing agent(s) issuch that the resulting combination is in the form of a formable and/orpliable putty that can be readily moulded into shape.

[0035] According to another aspect of the present invention there isprovided a medical composition, substantially as described above, inwhich a putty-like composition is suitable for use as a wound dressingor covering.

[0036] According to another aspect of the present invention there isprovided a medical composition, substantially as described above, inwhich a putty-like composition will substantially retain its state untilpressure or force is applied to it.

[0037] According to another aspect of the present invention there isprovided a medical composition, substantially as described above, inwhich a putty-like composition is substantially non-running—at up to 45°C.

[0038] According to another aspect of the present invention there isprovided a medical composition, substantially as described above, inwhich a putty-like composition will slowly dissolve over time in bodilyfluid.

[0039] According to another aspect of the present invention there isprovided a medical composition, substantially as described above, inwhich a slowly dissolving putty-like composition is suitable forinternal use.

[0040] According to another aspect of the present invention there isprovided a medical composition, substantially as described above, inwhich the combination of honey(s) and viscosity increasing agent(s) isin the form of a flexible sheet.

[0041] According to another aspect of the present invention there isprovided a medical composition, substantially as described above, inwhich a sheet-like embodiment is suitable for use as a wound dressing orcovering.

[0042] According to another aspect of the present invention there isprovided a medical composition, substantially as described above, inwhich a sheet-like composition possesses any one or more of thefollowing characteristics:

[0043] the inclusion of water absorbing, trapping, or removingcomponents to assist in the removal of free exudate;

[0044] is substantially non-running at body temperature;

[0045] will slowly dissolve in body fluids.

[0046] According to another aspect of the present invention there isprovided a medical composition, substantially as described above, inwhich a composition of any of the foregoing forms will soften at bodytemperature, when compared to room or storage temperature, to allow itto conform to the configuration of the wound or surface to which it isapplied or positioned, but which form remains substantiallynon-running—at up to standard body temperature, and more preferably to45° C.

[0047] According to a further aspect of the present invention there isprovided a wound dressing comprising at least a layer of a sheet orputty-like medical composition substantially as described above.

[0048] According to a further aspect of the present invention there isprovided a wound dressing comprising a sheet composed of multiple layersof some or all of the compositions substantially as described above.

[0049] According to a further aspect of the present invention there isprovided a wound dressing comprising a sheet composed of multiple layersof one, some or all of the compositions substantially as described abovein addition to a fabric to provide additional cohesive strength.

[0050] According to yet a further aspect of the present invention thereis provided a modified wound dressing comprising a medical compositionsubstantially as described above, applied to cover at least an area on abacking portion. The backing portion may be an adhesive material thatthe area that extends beyond the medical composition serves to adherethe dressing to the surface of the skin surrounding a wound.

[0051] According to another aspect of the present invention there isprovided a wound dressing, substantially as described in the precedingparagraph, in which the backing portion may comprise one or more layersof a suitable material.

[0052] According to another aspect of the present invention there isprovided a wound dressing, substantially as described above, in which anarea of an aforesaid composition overlies at least part of the backingportion.

[0053] According to another aspect of the present invention there isprovided a wound dressing, substantially as described above, in which anarea of the backing portion in which the medical composition is present,is defined by a number of smaller localised regions of the medicalcomposition distributed within the larger area (in which the medicalcomposition is present) on the backing portion.

[0054] According to yet a further aspect of the present invention thereis provided a wound dressing or medical composition, substantially asdescribed above, in which a honey present in same is chosen to haveanti-microbial or bacteriostatic properties.

[0055] According to yet a further aspect of the present invention thereis provided a wound dressing or medical composition, substantially asdescribed above, in which a chosen honey includes a non-peroxideanti-microbial or bacteriostatic component.

[0056] According to yet a further aspect of the present invention thereis provided a wound dressing or medical composition, substantially asdescribed above, in which a selected honey has a water content of 17.1%or lower.

[0057] According to yet a further aspect of the present invention thereis provided a wound dressing or medical composition, substantially asdescribed above, in which a selected honey has A_(w) of 0.94 or less,and preferably 0.86 or less.

[0058] According to yet a further aspect of the present invention thereis provided a wound dressing or medical composition, substantially asdescribed above, which has been sterilised with respect to clostridialspores by irradiation.

[0059] The present invention is directed to compositions, and productsbased thereon. Uses of the invention include applications in both humanand veterinary medicine.

[0060] Preferred embodiments of the invention include one or more honeysexhibiting bacteriostatic or anti-microbial properties. It has beenpreviously indicated that these properties in many honeys are wellknown, though there are difficulties associated with the use of honeyfor medical type uses. This includes the relatively fluid nature ofhoney and difficulties in localising it to the required area oftreatment. There are also other associated difficulties, such asproblems with wound exudate, and infection difficulties associated withmoist dressings, which the present invention also seeks to address aspart of its solutions for addressing the first problem.

[0061] Preferred embodiments of the present invention combine one ormore honeys (for simplicity of description only one honey will generallybe referred to in a composition described herein, though it should beremembered that this may be substituted by a blend of one or morehoneys) in combination with a viscosity increasing agent. Typically thenature of this viscosity increasing agent is such that the fluidity ofthe resulting composition is increased to the point that the resultingcomposition is substantially non-running. By non-running is meant acomposition which, if placed on an incline, will not flow down theincline. It is acceptable that the lower viscosity embodiments of thepresent invention may deform or bulge, but they should not break downand flow to any except the most minimal degree. For the purpose ofdefining the invention, such an inclination may be taken to be a slopeof 45°.

[0062] Further, it is envisaged that some embodiments of the presentinvention may soften at more elevated temperatures. Accordingly, unlessotherwise stated, non-running will generally be taken at a temperatureof 20° C. In many instances also, it is desirable that the compositionalso remains non-running at body temperature—which will be taken to be40° C. as many patients may also be exhibiting an elevated temperature.More preferably, compositions may be substantially non-running to 45° C.or higher.

[0063] The present invention may take a number of different forms. Theless viscous forms will comprise a relatively soft gel which may be usedas an ointment or salve. A potentially realisable advantage of the softgels is that under the mild pressure of applying a covering, they may beforced into a wound to make intimate contact with the presented surfaceof the wound. While this represents one possible use of such embodimentit is also envisaged that there are other uses for such gel-likeembodiments, such as for extruding into wound cavities. Previouslymentioned have been applications such as gels and salves for use onulcers and pustules. Varying gels may also be used intermediate thesurface to which a dressing is to be applied, and the dressing.Preferably the dressing is a honey based dressing (such as the sheettype embodiments herein).

[0064] In some applications the gel may even be used to help retain oradhere the dressing in the desired location. For instance a honey basedsheet embodiment typically possesses absorbent properties and can beemployed to help increase the viscosity of a thin layer of gel withwhich it is in contact. Hence a small amount of a softer honey based gelcan in some arrangements be used as an adhesive for adressing—particularly for ulcers etc. It is also envisaged that thereare other variations and embodiments of this principle, within the scopeof the present invention.

[0065] Such embodiments may be stored and dispensed in different ways.They may be contained in tubes and dispensed in the manner of normalsalves and ointments. They may also be contained in sealed capsules orpackages which may be opened to allow the contents to be squeezed intothe area of use. Other arrangements are also envisaged.

[0066] A further embodiment of the present invention is an embodimentwhich is perhaps best described as being putty-like. Such an embodimentmay be moulded or plied into shape by finger pressure, and willsubstantially retain that shape even under soft-to mild pressure. Thisnot only allows the thickness of the resulting composition, when used asa wound dressing, to be varied, but also allows it to be moulded for usein particular uses and locations. For instance, one could readilyenvisage its use when shaped to cover a wound on the bridge of a nose.This may be of some use in the area of cosmetic surgery.

[0067] As can also be appreciated, putty-like embodiments can also beused to provide some support and protection to some types of wounds,which gels and sheet-like embodiments (to be described later) may not beable to provide. Putty-like compositions of varying degrees of stiffnessand pliability are envisaged within the scope of the present invention.

[0068] The third main category of embodiments according to the presentinvention are the sheet-like embodiments which comprise a formed sheetwhich can be laid over a wound. These may be pre-formed into a varietyof shapes and sizes, though it is also envisaged that they may be easilytrimmed to shape.

[0069] Typically such embodiments will be flexible enabling them toaccommodate different contours and major irregularities on the surfaceover which they are applied. The degree of flexibility and softness mayalso be varied and it is also envisaged that the physicalcharacteristics may slowly change over time when used in a moistdressing—especially as wound exudate, body warmth, and other parametershave effect on their composition.

[0070] The three main categories of physical forms in which medicalcompositions according to the present invention may generally fall intohave been described above. Compositions from these general categoriesmay also be used in the preparation of other products—for instance, suchas a layer on a backing material in a wound dressing. This is not to saythe present invention cannot take other forms than described above,though for case of description it is determined that the categorising ofvarious embodiments into these three main groups is more convenient.This will assist in describing the various possible methods for theirpreparation and uses, which will be described later herein, and whichpreparations and uses may overlap between the various categories. Thereare no distinct boundaries between the categories, just bands in whichone merges into the next.

[0071] It is also envisaged that apart from being non-running variousembodiments of the present invention may possess other qualities. Forinstance, in some cases it is desirable for a medical compositionaccording to the present invention to contact a wound or other surfaceas intimately as possible. Because there is often some surfaceirregularity, sheet and putty-like embodiments of the present inventionmay not necessarily make such intimate contact, whereas the gel-likeembodiments will generally be more suitable for this purpose. Thiseither allows the options of ensuring there is layer of a gelcomposition intermediate in an overlying layer of a sheet or putty-likeembodiments, or alternatively looking at other methods of increasing theintimacy of contact.

[0072] One such latter method is to tailor the compositions such thatwhile they may be relatively firm yet pliable at room temperature forhandling and trimming, they substantially soften at body temperature, orat a temperature not too far above body temperature. This softeningshould be sufficient to allow the overlying composition to slowly mouldinto or contour to the wound—a process which may occur over minutesthrough hours. It is also envisaged, that in such embodiments arelatively thin layer of the material may be placed over the wound, andsome gentle localised heat applied to soften the material and betterconform with the surface to which it is applied. Ideally, for suchelevated-temperature-softening embodiments, the temperature to which itneeds to be heated should be in the range of 40°-50° C., and preferablytowards the lower end of this range.

[0073] As a further or alternative method of increasing contactintimacy, embodiments which soften or swell in the presence of moisturecan also be considered. In such cases, these may react to wound exudate,or even to a fine spray of water applied to the wound prior to theapplication of the dressing or covering. As many embodiments of thepresent invention are based on gelling substances, the selection ofappropriate gels, or the incorporation of the appropriate amounts ofvarious gels, makes this feasible. It is also envisaged that for thisembodiment, as well as other embodiments, sheets comprising multiplelayers of different formulations of compositions according to thepresent invention can be used. Hence a layer of water softening/swellingcomposition may be applied to a layer of a firmer composition. Analogousmulti-layer technology may also be incorporated for the heat sensitiveembodiments described above.

[0074] Other modifications which may be incorporated in variousembodiments include means for reducing free moisture such as woundexudate. Such embodiments perform a partial mopping up action to ensurethat the area under a dressing remains moist but not wet. Again this mayinvolve the use of suitably selected gelling agents which can absorb acertain amount of moisture from the wound. Other components may also beadded which perform such activities. These may include water absorbingcomponents, and water removing components (which may work by chemicalreaction) etc.

[0075] Embodiments of the present invention will, in their simplestform, comprise a combination of honey with a suitable viscosityincreasing agent. Typically this agent will comprise a substance whichforms a gel.

[0076] Selection of a suitable agent will involve a number ofconsiderations. Such considerations include the suitability for themedical or the intended use; stability over time; compatibility withhoney; and the ability to form a product having the desired physicalproperties—e.g. flexibility and strength etc. A number of otherconsiderations may also be involved, and commonly these will at least bepartially dictated by the requirements of the user and the intendedpurpose of a particular embodiment.

[0077] There are a number of suitable viscosity increasing agentsavailable and, as previously indicated, preferred embodiments of thepresent invention will rely on gelling agents. A number of gellingagents are available including various gums and polysaccharides,alginates, and both synthetic and natural polymeric compounds. Suchgelling agents are well known in the art,—in particular in the food andmedical arenas—and will not be discussed in any specific detail hereinapart from some representative examples given later herein. Some usefulprior art referencing the use of gelling agents in medical typeapplications include U.S. Pat. No. 4,948,575, U.S. 5,674,524, U.S.5,197,945, U.S. 5,735,812. U.S. 5,238,685, U.S. 5,470,576, U.S.5,738,860, U.S. 5,336,501 and U.S. 5,482,932. There are undoubtedly anumber of other patent specifications also referencing the use ofvarious gels and polymers for medical use and in particular for wounddressings. Reference is made to these documents as a background tovarious viscosity increasing agents which may find use with the presentinvention.

[0078] Preferred embodiments rely upon the alginate salts to form aproduct of the desired viscosity (e.g. gel, putty or pliable sheetetc.). The alginates appear to be especially suitable for use with thepresent invention as the physical properties of the gel product appearto be relatively easily controlled. In addition, they have proven to besuitable for many medical type uses.

[0079] Typically the gelled alginates are combined with the honey andany other optional components. By alginate selection one can use analginate which gels upon blending with honey, and/or rely upon anotherobserved property of some alginates which is to gel when a polyvalentcation is introduced. For this latter type the gel promotingagents—typically polyvalent cations—can be introduced to form a gelproduct of the desired consistency. Any moulding, extruding, or formingprocesses should also be performed at this time so that the firmerembodiments ‘set’ into the desired configuration. Machining (e.g.slicing) into the final form—such as sheets cut from a block—can also beincorporated into any manufacturing process.

[0080] Alginates also have another potentially realisable, advantage inthat introduced cations, or cations already part of the selectedalginate, can be of benefit in some situations. For instance, calciumcontaining alginates may be selected for embodiments used where there isbleeding, as calcium can promote blood clotting. There are also a widerange of cations which can be present or introduced into the variousalginates which can provide the user with some choice, thoughconsideration would need to be given to any potentially cytotoxic ions,such as ammonium ions.

[0081] Other potentially useful gelling agents include the hydrocolloidsand hydrogels. These components tend to absorb moisture to form a moisthealing environment, though tend to absorb less fluid than thealginates. Consequently, it is envisaged that they would not be used forembodiments for heavily exuding wounds in which the alginates would tendto offer better performance. However, it is envisaged that combinationsof various viscosity increasing agents may be used in particularembodiments, particularly if each imparts a slightly different propertywhich helps fulfil a particular specification required by the user. Forinstance the hydrocolloids or hydrogels may be incorporated into gellingblends to vary properties such as the amount of fluid absorbed from awound, etc.

[0082] Other optional materials may be included into various embodimentsof the present invention. Some of these have been addressed previously,though there are also others. These may include various activepharmaceuticals, particularly to address concerns which extend beyondthe ability of honey to address, or which augments or supplements theperformance of honey. Some examples include fungicides, additionalanti-bacterial agents etc.

[0083] Other optionally included components include filling materialswhich can change, the consistency and physical properties of anembodiment of the present invention. In particular, it is envisaged thatthe putties may include various solid particles to alter their physicalproperties. Even the physical properties of more solid embodiments, suchas sheets, may also be altered by the inclusion of particular fillers.These fillers may include various particulate or granular materialswhich may be substantially inert or show some activity. Some examplesinclude calcium carbonate, zinc oxide, barium sulphate etc. Otherfillers may include flexible or soft components, such as small beads.These may be of polymeric materials. Various filling agents widely usedin the pharmaceutical industry may be considered for use with thepresent invention.

[0084] Further, non-particulate materials, such as fibres, may also beincluded to alter the physical properties. The inclusion of randomlyplaced strands of alginate fibres, or even woven alginate fibrematerial, may be embedded or included in various embodiments. These,either in addition to or without other fillers, can also significantlyalter the physical characteristics of various forms of the presentinvention.

[0085] As an extension of this principle, it is desirable for someembodiments of the present invention to be attached to a suitablebacking material. This backing material may perform a number of roles,including acting as an intermediate between the honey composition andfurther backing layers, as a protective covering over the honeycomposition, or to further alter the physical properties of the honeycomposition. In particular it is envisaged that these arrangements willtypically be used for the sheet-like embodiments of the presentinvention and may include a number of various manufacturing techniquesincluding applying the un-gelled composition to the backing material sothat it bonds to same during gelling, or techniques for bonding thegelled honey composition to the backing material after the honeycomposition has substantially gelled or been formed. Variations andother manufacturing techniques are also possible.

[0086] As a further consideration in manufacturing, at least part of theanti-bacterial effect in some honeys is due to the presence of an enzymeproducing hydrogen peroxide. As for many enzymes this is temperaturesensitive, and thus any manufacturing technique should avoid heating thehoney to the extent that there is significant deactivation of theenzyme. In preliminary trials performed by the applicant, a maximumtemperature of 60° C. was sustainable for up to one hour without anysubstantial enzyme degradation. These factors will influence anymanufacturing technique.

BRIEF DESCRIPTION OF DRAWINGS

[0087] Further aspects of the present invention will become apparentfrom the following description which is given by way of example only andwith reference to the accompanying drawings in which:

[0088]FIG. 1 are perspective diagrammatic views of some possibleembodiments of a dressing;

[0089]FIG. 2 is a side view of a possible embodiment of a dressing, and

[0090]FIG. 3 are side views of further possible embodiments of adressing.

BEST MODES FOR CARRYING OUT THE INVENTION EXAMPLE 1

[0091] This group of examples is based on the use of alginates as agelling and viscosity increasing agent for honey.

[0092] As a general procedure, finely powdered sodium alginate (the useof other alkaline metal alginates may also be considered) is blendedwith honey warmed to approximately 60° C. It is desirable that thistemperature is not exceeded so as to avoid degradation of any hydrogenperoxide producing enzyme in the honey.

[0093] As the alginate slowly dissolves and absorbs water from thehoney, a gel begins to form. Stirring should continue during thisprocess so that as any yet unblended and ungelled alginate does norsettle out.

[0094] At this point a number of optional procedures may be followeddepending upon the nature of the final product. For instance:

EXAMPLE 1a

[0095] For high viscosity products (e.g. sheets) the gel should berolled into a sheet of the desired thickness as soon as it has gelledsufficiently to be able to handle the rolling procedure. The sheetsshould be maintained at a temperature high enough for hydration of thealginate to be completed and the full viscosity to be achieved for thisparticular product. By way of example this may be 60° C. forapproximately one hour, or for longer periods at lower temperatures.This may vary according to the nature of the selected honey, theproperties of the alginate selected etc., and thus some minor trialexperimentation may be required to achieve an embodiment having theprecise characteristics required by the user.

EXAMPLE 1b

[0096] As an alternative to Example 1a, a low viscosity product (e.g. agel formulation or some putties) the blended mixture should be held atthe elevated temperature to allow hydration of the alginate to becompleted and the full viscosity achieved before it is packed or formedinto the desired configuration. Some softer sheet-like embodiments maybe also formed according to this method.

EXAMPLE 1c

[0097] For intermediate products, such as the putties, optional fillersand additives altering the physical properties of the resulting product(e.g. fibres) are preferentially introduced after the alginate has beensubstantially homogeneously dispersed throughout the honey and while thegelling process is occurring. The inclusion of such additives may alsooccur at other times, though it is noted that their inclusion prior toalginate addition may interfere with the ready blending of the alginatewith the honey in some instances, while addition at a later stage may bemore difficult for some embodiments e.g. the addition of fibres aftergelling has substantially occurred.

EXAMPLE 2

[0098] Many alginates also exhibit gelling and cross linking propertiespromoted by the presence of polyvalent cations. These often tend to formtougher and less soluble alginate materials and thus may find use in anumber of embodiments for altering physical characteristics of theresulting product. Typically it is envisaged that such modification willbe used primarily for the sheet-like embodiments, particularly as a wayof increasing the strength or solubility properties of the resultingsheet.

[0099] The polyvalent cations may be introduced in a number of ways,including the introduction of a soluble solution of polyvalent cationsduring the blending procedure. Preferably, this should be after gellingof the blend has initiated so as to avoid thickening reactions whichinterfere with the dispersion and hydrating of all of the sodium (orother) alginate being blended with the honey. However, as can beappreciated, adding polyvalent cations at different points cantheoretically substantially alter the characteristics of the resultingproduct and thus a number of options remain open to the user to allowthem to tailor the physical characteristics of various embodimentsaccording to the intended end use and user requirements.

[0100] A range of polyvalent cations may be used, though toxicityconsiderations need to be given. It is anticipated that soluble calciumsalts, such as calcium chloride, may be introduced at relatively lowconcentrations to promote the various gelling and cross linkingreactions.

EXAMPLE 3

[0101] This example is directed to the forming of a gel into sheets.This may be achieved by placing a gel such as from Examples 1a or 1bbetween sheets of a non-wettable material—on a lab scale this comprisedplastic or wax paper—and rolling it to a uniform thickness.

[0102] As a variation, a gauze fabric or other suitable material may beplaced on top of the lower non-wettable sheet prior to the pouring ofthe gel. The rolling procedure is completed with the result being asheet-like gel bonded to the gauze. FIG. 3a illustrates the result ofsuch an embodiment, with the sheet of gelled honey (31) at leastpartially impregnating and bonding to the gauze or comparable material(33).

[0103] As a further variation, reinforcement may be provided in thecentre of the gel. Here a layer of gel may be poured to cover the lowersheet, followed by placement of the gauze (or other reinforcing/backingmaterial) followed by another layer of gel. The rolling procedure isthen performed resulting in a sheet in which the gauze or fabric isembedded within the sheet. FIG. 2a illustrates the result of such amethod with the gauze (or other suitable material) (23) embedded withinthe gelled honey (21). As a further option this may be bonded to afurther backing sheet (25). This can be achieved by pouring the lowerfirst layer of gelled honey (21) onto this layer (25), prior to placingthe gauze (23) and top gel layer.

[0104] As a variation of this technique, the gel may be formed into twothin sheets, with the gauze then sandwiched between the sheets of thegel (still at an elevated temperature) and the rolling processre-performed on the sandwiched layers.

EXAMPLE 4

[0105] For a high viscosity product which is highly absorptive andsuitable for use on heavily exuding wounds, the procedures describedabove are performed with 1 gram of sodium alginate with 5±2.5 grams ofhoney.

EXAMPLE 5

[0106] For a flexible product which is moderately adhesive andmoderately absorptive and suitable for use on lightly exuding wounds, 1gram of sodium alginate is combined with 10±2.5 grams of honey.

EXAMPLE 6

[0107] For a highly flexible and adhesive product suitable for use ondry wounds, 1 gram of sodium alginate is combined with 15±2.5 grams ofhoney.

EXAMPLE 7

[0108] For a lower viscosity product suitable for use as a gel (such aspacked into a tube) to fill cavities and wounds, 1 grain of sodiumalginate is combined with 17.5 grams or greater of honey, with thepreferred amount being around 20 grams.

EXAMPLE 8

[0109] For a putty-like product, to the combinations outlined inExamples 6 and 7 is included sufficient fine filler material to achievethe desired consistency. Preferred filling agents include finelypowdered calcium carbonate. Despite the insolubility of this component,it may nevertheless have some effect on any gelling reaction should itbe added while gelling is still occurring. Previous, comments onpolyvalent cations are referred to. The role of calcium in promotingblood clotting is also noted.

[0110] Other gelling agents, such as hydrogels, and various colloids,may be also included in these embodiments to vary the elasticity,pliability, and other physical characteristics of the putty. These maybe in the form of blended components contributing to gelling, or even asfirm components blended into the gel mixture as fillers.

[0111] These techniques may even be used in other embodiments Forinstance, FIG. 3b illustrates the presence of fibrous strands (35) (e.g.alginate fibres) and particulate matter (37) dispersed in the gelledmatrix (31).

EXAMPLE 9

[0112] This example deals with the selection of honey for use with thepresent invention.

[0113] A large amount of this information is already referenced in theprior art identified earlier within this specification, and inparticular publications by the inventor—Peter Molan. These publicationsreference the bacteriostatic and bactericidal effects of various honeysand thus reference may be made to this literature for identifying usefulbactericidal honeys.

[0114] In addition, it is noted that while the osmolarity effect andperoxide effects of many honeys contribute to their antibacterialproperties, research has also indicated that other components in somehoneys also contribute to any bactericidal effects. It is considered,that for use in the present invention, these latter groups of honeys maybe preferred, particularly for dressing and embodiments which may bestored for an extended period of time, or used under conditions whichmay result in degradation of any peroxide forming enzyme in the honey.

[0115] As can be envisaged also, the limitation on the maximumtemperature to which the honey is subjected during manufacturing (toavoid enzyme degradation) may be overly restrictive for someembodiments. In such cases, honeys possessing bactericidal effects otherthan from the peroxide, may find use hare as it appears that some of theactive components would be less sensitive to temperature.

[0116] Some preferred honeys for use with the present invention includehoneys derived from leptospermum species such as, for instance, manukaand jellybush. These honeys tend to exhibit significant antibacterialproperties arising from non-peroxide factors present, in addition toperoxide associated antimicrobial properties.

[0117] Additional honeys of interest include those derived from rewarewa(Knightia excelsa), kanuka (Kunzea cricoides), and from the honeydewpresent on bach (Nothofagus solandri).

EXAMPLE 10

[0118] An alternative method for the manufacturing process, thatinvolves less heating of the honey than would be required to gel honeycontaining a powdered form of the gelling agent dispersed in it, is tohydrate the gelling agent in hot water then mix this solution of thegelling agent with the honey and then dry the mixture by applying heatand/or a flow of air to a film of the mixture. This alternative methodfor the manufacturing process is particularly useful for use withgelling agents which do not hydrate as readily as alginates, such aspectin or plant gums.

EXAMPLE 11

[0119] A final consideration in any manufacturing process is thepresence of contaminants in honey. Being a natural product, there may bea variety of naturally occurring contaminants in the honey. This mayinclude toxic substances from honeys sourced from particularflowers—ideally these honeys should be avoided unless there are somebenefits for including such substances in a particular application. Forinstance, many toxic plants produce chemicals, such as digitalis, whichhave specific medical uses when used in controlled amounts.

[0120] A more prevalent problem is the presence of microbial spores suchas clostridial spores. However, it has been demonstrated that these maybe eliminated by gamma-radiation of honey, without destruction of any ofthe antibacterial activity of honey, and thus irradiation techniques maybe considered for various embodiments

EXAMPLE 12

[0121] On a large scale, the application of gelled honey to a backingsubstrate may differ substantially from that described herein. It isenvisaged that one option is to ‘print’ or ‘paint’ the gellingcomposition on to the substrate prior to it fully setting. Hence areascan be printed or painted on to the appropriate areas of a substratematerial, which can then be trimmed into an appropriate Size, such asfor a dressing.

[0122]FIG. 1a illustrates a dressing (11) which may have been producedby this method (but also by other techniques). Here an area (13) ofgelled honey matrix has been applied centrally within a substrate (15).

[0123]FIG. 1b is an enlargement showing that in these embodiments thelayer of gelled composition need not be continuous but may be made up ofsmaller regions (17). This may also allow a more open and breathablewound contact portion, which may be advantageous in some instance.

[0124] As can be appreciated also, various techniques described hereincan be combined to produce more complex embodiments encompassing anumber of different features

EXAMPLE 13

[0125] Uses of varying embodiments of the present invention are varied.It is envisaged that sheet like embodiments will be used in applicationssimilar to those for which convention dressings are used.

[0126] Gels and salves can be used in the manner of conventional gelsand salves. They may be applied directly into a wound cavity whichrepresents an application for which many gels and salves possessingantibacterial properties may not be able to be used. Topical use insidethe oral cavity for ulcers and abscesses of the mouth and gum diseasesare another potential use of varying gel-like and other embodiments

[0127] Gel-like embodiments may also be used as an intermediate betweenthe substrate (e.g. skin or wound etc.) and a dressing, preferably ahoney-based dressing such as described herein. This can help eliminateany air spaces, and fill irregularities in the substrate surface thatthe dressing is unable to conform to.

[0128] Further, if it is in a drying environment, many gel likeembodiments may increase in viscosity. A gel used between dry skin (suchas may surround a wound) and an absorbent dressing (such as a honeybased sheet dressing described herein) can thicken over time as moisturemigrates from it. In such a case the applied gel can act in the role ofa mild adhesive or bonding agent to help keep the dressing in place.This can be of use in a number of applications, including for instancearound ulcers, boils, pustules, carbuncles, acne and a variety of other‘dry’ afflictions as well as taking advantage of normal dry skinsurrounding wounds and other injured areas.

[0129] Thicker, pliable and mouldable embodiments have a range ofpotential applications including applications where Some support may berequired in the wound area. Such embodiments may also find use in dentaland oral applications, including temporary fillings or covers for teethand gums.

[0130] As can be appreciated, there is a wide potential range ofapplications for the varying embodiments of the present invention. Itwill be appreciated that many such uses will become apparent to theskilled reader and addressee of the art in light of the descriptiongiven herein, and it should be recognised that the limited range ofpossible uses and examples given herein are by way of example only anddo not represent the entire range of potential uses.

EXAMPLE 14

[0131] The following data represents anecdotal trial results from use ofvarying embodiments of the present invention.

EXAMPLE 14 a

[0132] In a leg ulcer where exudation was severe, initial treatmentconsisted of alginate based dressing sold for heavily exudating wounds.After no observable progress was made over extended period of time, awound dressing according to the present invention was trialled. Thisconsisted of 5 mm thick high alginic proportion (1 part alginate:5, parthoney) pliable sheet positioned over wound and bandaged over. Wounddressing was changed daily and new sheet applied. Exudate was absorbedsatisfactorily by dressing. An observable result was significantlyreduced exudation from wound within a few days. Wound became manageable,and problems associated with prior art alginate dressings wereeliminated.

EXAMPLE 14b

[0133] In a diabetic foot ulcer on foot underside, pliable sheetembodiment was used. Most prior art dressings were unsuitable for thislocation as squeezed out from weight on fool. This was not a heavilyexudating wound though high alginic proportion (1:5) was used to providefirm sheet. Wound showed satisfactory healing despite known difficultyof healing of diabetic foot ulcers, and failure of prior art productstried up until use of present invention, to result in any improvement orhealing.

EXAMPLE 14c

[0134] In a smashed jaw with eroding jaw bone from infection, there wasno improvement over 18 month period using traditional techniques. Painin patient was present and occasionally acute. In this case a pliableputty was used (1:5 ratio putty) and was fashioned to appropriate shapeto cover wound. This dressing was replaced regularly at intervals ofseveral hours (due to partial dissolving of putty by saliva). Woundhealing progressed satisfactorily with rapid pain relief as addedbenefit.

EXAMPLE 14d

[0135] An alternative embodiment using agar, which sets into a solidgel, may he used on skin grafts to immobilise the graft—this is inaccordance with current practice of occasionally using a dressing tohold graft in place by surgeons. Typically a sheet type embodimentutilising 1-10% agar by weight. Sheet of gauze is embedded into 1 mmthickness of gel (around 1% agar). Preparation may be by heatingdissolved agar solution first and then stirring heated agar solutioninto cold honey. This is then applied over gauze to embed. The result issoft pliable sheet, with tackiness. This can be overlaid over graft orwound etc., and tackiness helps grip skin and prevent sliding.

[0136] This embodiment utilises a particulate gel (e.g. agar whereparticles stick to each other in a 3-d net) as opposed to a continuousgel (e.g. alginate) which tie up the water but where particles can rollover each other to give pliability and mouldable characteristics.Different embodiments may use one or other of these types of gellingagents. Can also blend different gel types to give products ofintermediate characteristics.

EXAMPLE 14e

[0137] One other appln is to use softer formulation (1:10-1:20 alginatetype typically) on acne. Similar uses on boils etc. Such embodiments aremore discreet than sticking plaster and may also be used for mouthulcers. Acne embodiments may be in the form of a gel, salve, orointment, and may also include other components such as pigments(preferably flesh coloured) and/or sulphur.

[0138] Aspects of the present invention have been described by way ofexample only and it should be appreciated that modifications andadditions may be made thereto without departing from the scope thereof.

1. A medical composition comprising the combination of one or morehoneys with a viscosity increasing agent.
 2. A medical composition asclaimed in claim 1 in which at least 50% (by weight) of the compositionis honey.
 3. A medical composition as claimed in claim 1 in which theviscosity increasing agent is an alginate based material.
 4. A medicalcomposition as claimed in claim 1 in which the viscosity increasingagent is a natural product based gelling agent.
 5. A medical compositionas claimed in claim 1 in which the combination is such that theresulting composition is in the form of a non-running gel.
 6. A medicalcomposition as claimed in claim 5 in which the viscosity of the gelcomposition is such that it is suitable for application as an ointmentor salve.
 7. A medical composition as claimed in claim 5 in which theviscosity of the gel composition is such that it is suitable forextrusion to fill wound cavities.
 8. A medical composition as claimed inany one of claims 5 through 7 in which the gel composition issubstantially non-running at body heat.
 9. A medical composition asclaimed in any one of claims 5 through 7 in which the gel-formedcomposition is substantially non-running at 45° C.
 10. A medicalcomposition as claimed in any one of claims 5 through 9 in which thegel-formed composition includes moisture absorbing, trapping, orremoving agents suitable for removing exudate from a wound such that thegel-formed composition remains substantially non-running for an extendedperiod of time after application to a wound when compared to a similarcomposition in which the said water trapping, removing or absorbingagents are absent.
 11. A medical composition as claimed in claim 1 inwhich the combination of honey and viscosity increasing agent(s) is suchthat the resulting combination is in the form of a formable and/orpliable putty that can be readily moulded into shape.
 12. A medicalcomposition as claimed in claim 11 in the form of a putty-likecomposition suitable for use as a wound dressing or covering.
 13. Amedical composition as claimed in claim 11 in the form of a putty-likecomposition and which will substantially retain its state until pressureor force is applied to it.
 14. A medical composition as claimed in claim11 in the form of a putty-like composition and which is substantiallynon-running at up to 45° C.
 15. A medical composition as claimed inclaim 11 in the form of a putty-like composition will slowly dissolveover time in bodily fluid.
 16. A medical composition as claimed in claim15 in the form of a slowly dissolving puttylike composition suitable forinternal use.
 17. A medical composition as claimed in any one of claims11 through 16 which includes an alginate as a viscosity increasingagent.
 18. A medical composition as claimed in any one of claims 11through 16 which includes a gelling agent forming a continuous gel, as aviscosity increasing agent.
 19. A medical composition as claimed inclaim 1 in which the combination of honey(s) and viscosity increasingagent(s) is in the form of a flexible sheet.
 20. A medical compositionas claimed in claim 19 in which said sheet-like embodiment is suitablefor use as a wound dressing or covering.
 21. A medical composition asclaimed in claim 19 which uses a gelling agent forming a continuous gel,as a viscosity increasing agent.
 22. A medical composition as claimed inclaim 21 in which the gelling agent is an alginate.
 23. A medicalcomposition as claimed in claim 19 which uses a gelling agent forming aparticulate gel, as a viscosity increasing agent.
 24. A medicalcomposition as claimed in claim 23 in which the gelling agent is an agaror gelatine.
 25. A medical composition as claimed in claim 19 which usesas viscosity increasing agents a combination of gelling agents,including at least one gelling agent which typically forms a continuousgel, and at least one gelling agent which typically forms a particulategel.
 26. A medical composition as claimed in any one of claims 19through 25 in which said sheet-like composition possesses any one ormore of the following characteristics: the inclusion of water absorbing,trapping, or removing components to assist in the removal of freeexudate; is substantially non-running at body temperature; will slowlydissolve in body fluid.
 27. A medical composition as claimed in any oneof claims 19 through 25 which will soften at body temperature, whencompared to room or storage temperature, to allow it to conform to theconfiguration of the wound or surface to which it is applied orpositioned, but which form remains substantially non-running—at up tostandard body temperature, and more preferably to 45° C.
 28. A wounddressing consisting of at least one layer of a sheet-like medicalcomposition as claimed in any one of claims 19 through
 27. 29. A wounddressing as claimed in claim 28 which includes a reinforcing material.30. A wound dressing as claimed in claim 29 in which the reinforcingmaterial is selected from a group including: gauze, mesh, random fibres,and woven fabric.
 31. A wound dressing as claimed in claim 29 or claim30 in which the reinforcing material is embedded in the medicalcomposition.
 32. A modified wound dressing consisting of a wounddressing as claimed in any one of claims 28 through 31 applied to abacking material.
 33. A modified wound dressing as claimed in claim 32in which the backing material is a fabric.
 34. A modified wound dressingas claimed in claim 32 in which the backing material includes adhesiveareas other than in areas coextensive with the wound dressing, allowingthe modified wound dressing to be applied and adhere to skin or otherapplication surface.
 35. A modified wound dressing consisting of abacking portion on which is present a wound patch including a medicalcomposition as claimed in any one of claims 1 through 27, and in whichan area of the backing portion in which the medical composition ispresent, is defined by a number of smaller localised regions of themedical composition distributed within the larger area (in which themedical composition is present) on the backing portion.
 36. A medicalcomposition consisting of honey in combination with a viscosityincreasing agent, for use in the treatment of a pustule, the compositionbeing substantially non-running at normal body temperature.
 37. Amedical composition consisting of honey in combination with a viscosityincreasing agent, for use in dressing wounds, the composition beingsubstantially non-running at normal body temperature.
 38. A medicalcomposition consisting of honey in combination with a viscosityincreasing agent, for use in the treatment of ulcers, the compositionbeing substantially non-running at normal body temperature.
 39. Amedical composition consisting of honey in combination with a viscosityincreasing agent, for use in the treatment of burns, the compositionbeing substantially non-running at normal body temperature.
 40. Amedical composition consisting of honey ill combination with a viscosityincreasing agent, for use in covering skin grafts, the composition beingsubstantially non-running at normal body temperature.
 41. The medicalcomposition of claim 40 in which the viscosity increasing agent is anagar.
 42. The use of honey in combination with a viscosity increasingagent in the manufacture of a substantially non-running composition foruse in addressing or treating any one of: acne, pustules, burns,recovery of skin grafts, ulcers, wounds, and including exudating wounds.43. The use of honey in combination with a viscosity increasing agent inaddressing or treating any one of: acne, pustules, burns, recovery ofskin grafts, ulcers, wounds and including exudating wounds.
 44. The useof a medical composition as claimed in any one of claims 1 through 27 inaddressing or treating any one of: acne, pustules, burns, recovery ofskin grafts, ulcers, wounds and including exudating wounds.
 45. The useof a wound dressing as claimed in any one of claims 28 through 31 inaddressing or treating any one of acne, pustules, burns, recovery ofskin grafts, ulcers, wounds and including exudating wounds.
 46. The useof a modified wound dressing as claimed in any one of claims 32 through35 in addressing or treating any one of; acne, pustules, burns, recoveryof skin grafts, ulcers, wounds and including exudating wounds.
 47. Amedical composition in the form a salve, gel, or ointment, consisting ofa honey in combination with a viscosity increasing agent, saidcomposition also including at least one of: a pigment, and sulphur. 48.The composition of claim 47 which includes a pigment, said pigment beingflesh coloured.
 49. A medical composition as claimed in any one ofclaims 1 through 27 in which a honey present in same is chosen to haveanti-microbial or bacteriostatic properties.
 50. A medical compositionas claimed in claim 49 in which a chosen honey includes a non-peroxideanti-microbial or bacteriostatic component.
 51. A medical composition asclaimed in claim 49 or claim 50 in which a selected honey has a watercontent of 17.1% or lower.
 52. A medical composition as claimed in anyone of claims 49 through 51 in which a selected honey has A, of 0.94 orless.
 53. A medical composition as claimed in any one of claims 49through 51 in which a selected honey has A_(w) of 0.86 or less.
 54. Amedical composition as claimed in any one of claims 1 through 27, or 49through 53 which has been sterilised with respect to clostridial sporesby irradiation.
 55. A wound dressing as claimed in any one of claims 28through 35 in which a honey present in same is chosen to haveanti-microbial or bacteriostatic properties.
 56. A wound dressing asclaimed in claim 55 in which a chosen honey includes a non-peroxideanti-microbial or bacteriostatic component.
 57. A wound dressing asclaimed in claim 55 or claim 56 in which a selected honey has a watercontent of 17.1% or lower.
 58. A wound dressing as claimed in any one ofclaims 55 through 57 in which a selected honey has A_(w) of 0.94 orless.
 59. A wound dressing as claimed in any one of claims 55 through 58in which a selected honey has A_(w) of 0-86 or less.
 60. A wounddressing as claimed in any one of claims 28 through 35, or 55 through 59which has been sterilised with respect to clostridial spores byirradiation.